In order to dispel the accusations, an attorney for the FDA claimed that the organization just made recommendations against using or prescribing Ivermectin. Nevertheless, prominent doctors hsve launched a lawsuit against the FDA over suppression of Ivermectin to treat COVID.
In a lawsuit filed by three physicians alleging the U.S. Food and Drug Administration (FDA) of interfering with their administration of ivermectin to COVID-19 patients, an FDA representative argued that encouraging people to “stop” taking the medication was only a recommendation.
The notion that the “recommendation,” which involved disparaging the medication as a “horse de-wormer,” drove hospitals and pharmacies to prohibit its use for COVID-19 does not mean the FDA is to blame, argued Isaac Belfer in a hearing in federal court in Texas.
“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do,” Belfer said November 1,
Attorneys for the physicians, including Dr. Paul Marik, referenced three FDA internet posts, including a tweet with a photo of a horse that said: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
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The tweet linked to an FDA web page titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” On a separate page, the FDA stated: “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.” A subsequent tweet said: “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”
Ivermectin, a safe and efficient Nobel Prize-winning, FDA-approved medication for several illnesses, can be prescribed by a physician “off label” for COVID-19, and 93 randomized controlled trials validate the reported success of many physicians worldwide.
Belfer, the FDA’s attorney, said that the agency was just stating “why you should not take ivermectin to treat COVID-19.”
“They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
Belfer emphasized: “They use informal language, that is true. It’s conversational but not mandatory.”
However, Jared Kelson, an attorney for the physicians, told the court that the FDA’s position does not justify the wording it used: “Stop it. Stop it with the ivermectin.”
The FDA’s actions “clearly convey that this is not an acceptable way to treat these patients,” he contended.
Kelson said that if the government “is going to label ivermectin a horse medicine or a horse de-wormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out.”
He claimed that the FDA had effectively demonized “a common drug that has been used for a very long time and has been dispensed in billions of doses.”
The government has filed a motion to dismiss the case, claiming that the plaintiffs lack standing because the alleged injuries are unrelated to the FDA.
Kelson contended otherwise.
“It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the ivermectin,’ I don’t understand how that would not be traceable back to the FDA,” he said.
The suit claims that the FDA interfered with doctors’ ability to practice medicine, in violation of the Federal Food, Drug, and Cosmetic Act and other statutes. It requests that the court order the FDA to refrain from issuing guidelines on whether ivermectin should be employed to combat COVID-19. Trump appointee U.S. District Judge Jeffrey Brown has stated that he will rule “as quickly as we can for y’all.”
Marik, the chief of pulmonary and critical care medicine at Eastern Virginia Medical School and the director of the intensive care unit at Sentara Norfolk General Hospital, began treating COVID-19 patients with ivermectin in 2020. Following the FDA’s statements, the medical school instructed him to remove his ivermectin regimen from its website. Sentara also cited the FDA in a memo urging hospitals to discontinue the use of ivermectin against COVID-19.
Marik filed a lawsuit against Sentara last October, claiming that Virginia’s Advanced Directive statute grants hospitalized patients the freedom to select what care they receive as long as a doctor deems it acceptable.
According to the suit, the statute does not read “as determined by the hospital,” but rather “as determined by (their) attending physician.”
Ivermectin, dubbed (read below) a “wonder drug” in the Journal of Antibiotics, was demonstrated to have powerful antiviral and antiparasitic characteristics in both in-vitro and in-vivo tests long before the COVID-19 outbreak. In the spring of 2020, ivermectin was on the World Health Organization’s list of vital medications and has been administered to refugees entering the U.S.
A study published in June 2020 discovered that ivermectin suppresses SARS-CoV-2 replication in vitro.
Driven by science and evidence?
David R. Henderson, a research fellow at the Hoover Institution at Stanford University, and Charles L. Hooper posed the question, “Why Is the FDA Attacking a Safe, Effective Drug?” in a Wall Street Journal op-ed piece on ivermectin in July 2021.
“If the FDA were driven by science and evidence, it would give an emergency-use authorization for ivermectin for COVID-19. Instead, the FDA asserts without evidence that ivermectin is dangerous,” they wrote.
They draw attention to the following statement found at the bottom of the FDA’s warning about ivermectin: “Meanwhile, effective ways to limit the spread of COVID-19 continue to be to wear your mask, stay at least 6 feet from others who don’t live with you, wash hands frequently, and avoid crowds.”
Henderson and Hooper asked: “Is this based on the kinds of double-blind studies that the FDA requires for drug approvals? No.”
Henderson served as a senior health economist for the Council of Economic Advisers under President Ronald Reagan. Hooper is the head of the pharmaceutical industry consulting company Objective Insights.
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